RESTIFFIC™ Foot Wrap Reduces Moderate to Severe Restless Leg Syndrome

NCT02386423 | Completed DMC

• 1 other identifier: Sorg1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and efficacy of RESTIFFIC™, a foot wrap that produces adjustable targeted pressure on specific muscles in the feet, to reduce the symptoms of moderate to severe primary Restless Legs Syndrome.

Conditions

Restless Leg Syndrome

Keywords

RLS; Willis-Ekbom

Outcome Measures

Primary Outcomes (1)

• Change in International Restless Legs Syndrome Study Rating Scale

  Change in International RLS Study Group (IRLSS) Rating Scale from baseline to Day 56 Study end

Secondary Outcomes (1)

• Clinical Global Impression Scale

  Four CGI Scales, one each on Days, 1, 29, 36, and 57

Other Outcomes (2)

• Meta-analysis used to compare change in IRLSS scores in RESTIFFIC to change in IRLSS scores for ropinirole and placebo pill (historic reports)

  Baseline to end of study

• Number and type of adverse events as a measure of safety and tolerability of RESTIFFIC™ vs ropinirol and placebo (historic reports)

  Baseline to study end.

Study Arms (1)

RESTIFFIC

EXPERIMENTAL

RESTIFFIC™ Brand Pressure Application System

Device: RESTIFFIC™ Brand Pressure Application System

Interventions

RESTIFFIC™ Brand Pressure Application System DEVICE

The device, RESTIFFIC™, was administered intermittently through the course of the study: one-week baseline period without the device (days 1-7), three weeks of initial testing with the device (days 8-28), a subsequent one-week period without the device (days 29-35), and three weeks of subsequent testing with the device (days 36-56).

Also known as: Restless Leg Relaxer

RESTIFFIC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Otherwise healthy adults between the ages of 18 and 75 years who were diagnosed with moderate to severe RLS were recruited from Erie and the surrounding regions. The patient was examined by the physician and screened using the medical history, the International RLS study group diagnostic criteria, and International RLS Study (IRLSS) Rating Scale.
• To be included, patients had to have: (1) a total score of 15 or greater on the International RLS Rating Scale; (2) evening and nighttime symptoms with sleep impairment (by self-report) due to RLS; and (3) RLS for at least six months with symptoms at least two to three times per week. The potential was for at least 12 and as many as 42 episodes of RLS during the treatment period.

You may not qualify if:

• The patient was excluded if he/she had any serious medical conditions or conditions that may have presented a safety concern or that may have impacted efficacy assessment, eg, taking drugs like antidepressants known to affect RLS. Medical conditions included, but were not limited to: claudication, nerve problems, fragile, thin skin, impaired wound healing; poor circulation, injury to feet or legs, movement problems, inability to sit still or remain motionless, involuntary movements similar to a tic, sleep disorders, parasomnias involving abnormal movements, narcolepsy, obstructive sleep apnea, nighttime discomfort not due to RLS, secondary RLS, or Parkinson's Disease. Patients on drug treatment for RLS must have been discontinued treatment for at least 30 days. (Note: None of our patients were on drug treatment for RLS.) Through history and physical examination, the physician distinguished RLS from other disorders such as periodic Limb Movement Disorder (footnote 5)

Sponsors & Collaborators

• Lake Erie Research Institute: lead

Study Sites (1)

Baycity Associated in Podiatry Inc

Erie, Pennsylvania, 16509, United States

Location

Related Publications (4)

• Bogan RK, Fry JM, Schmidt MH, Carson SW, Ritchie SY; TREAT RLS US Study Group. Ropinirole in the treatment of patients with restless legs syndrome: a US-based randomized, double-blind, placebo-controlled clinical trial. Mayo Clin Proc. 2006 Jan;81(1):17-27. doi: 10.4065/81.1.17.

  PMID: 16438474 BACKGROUND

• Trenkwalder C, Garcia-Borreguero D, Montagna P, Lainey E, de Weerd AW, Tidswell P, Saletu-Zyhlarz G, Telstad W, Ferini-Strambi L; Therapy with Ropiunirole; Efficacy and Tolerability in RLS 1 Study Group. Ropinirole in the treatment of restless legs syndrome: results from the TREAT RLS 1 study, a 12 week, randomised, placebo controlled study in 10 European countries. J Neurol Neurosurg Psychiatry. 2004 Jan;75(1):92-7.

  PMID: 14707315 BACKGROUND

• Walters AS, Ondo WG, Dreykluft T, Grunstein R, Lee D, Sethi K; TREAT RLS 2 (Therapy with Ropinirole: Efficacy And Tolerability in RLS 2) Study Group. Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: a 12-week, double-blind, randomized, parallel-group, placebo-controlled study. Mov Disord. 2004 Dec;19(12):1414-23. doi: 10.1002/mds.20257.

  PMID: 15390050 BACKGROUND

• Kuhn PJ, Olson DJ, Sullivan JP. Targeted Pressure on Abductor Hallucis and Flexor Hallucis Brevis Muscles to Manage Moderate to Severe Primary Restless Legs Syndrome. J Am Osteopath Assoc. 2016 Jul 1;116(7):440-50. doi: 10.7556/jaoa.2016.088.

  PMID: 27367949 DERIVED

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• Phyllis J Kuhn, PhD

  Lake Erie Research Institute

  STUDY DIRECTOR

• Daniel J Olson, DPM, AACFAS

  Baycity Associates in Podiatry Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 11, 2015
• Study Start: April 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

US (1)